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calendar

1,906 catalysts · 4,728 grant · 3,350 8k filing · 2,718 approval · 2,708 device 510k · 2,000 device recall · 1,906 device pma

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type: device pma×from 2025-06-10×clear all
type
  • grant4,728
  • 8k filing3,350
  • approval2,718
  • device 510k2,708
  • device recall2,000
  • device pma1,906
device adverse event
1,000
  • recall686
  • earnings584
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jun 9, 2025

    28
    ›Jun 10, 2025device pma432d agoShockwave Medical, Inc. — Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Cathete (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: QMG. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 10, 2025device pma432d agoMedtronic, Inc. — Activa™ and Percept™ Deep Brain Stimulation Therapy System (PMA supplement)Medtronic plc

    Supplement type: Real-Time Process. Product code: MHY. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Jun 10, 2025device pma432d agoDavol Inc., Sub. C. R. Bard, Inc. — Avitene Flowable Collagen Hemostat (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: LMF. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Jun 10, 2025device pma432d agoOrganox Limited — OrganOx metra System (PMA supplement)

    Supplement type: Real-Time Process. Product code: QQK. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Jun 10, 2025device pma432d agoMerz North America, Inc. — RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, Jawline indication (PMA supplement)Sustained Therapeutics Inc

    Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Jun 10, 2025device pma432d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Jun 10, 2025device pma432d agoThe Straumann Company — BIORA EMDOGAIN(R) (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: NQA. Advisory committee: DE. Decision: APPR

    full page →fda device pma ↗
    ›Jun 11, 2025device pma431d agoW. L. Gore & Associates, Inc. — GORE TAG Thoracic Branch Endoprosthesis (TBE Device) (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 11, 2025device pma431d agoVentana Medical Systems, Inc. — PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PMA supplement)MERIT MEDICAL SYSTEMS INC

    Supplement type: Normal 180 Day Track. Product code: MVC. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Jun 11, 2025device pma431d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® AAA Endoprosthesis (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 11, 2025device pma431d agoRxsight, Inc. — Light Adjustable Lens, Light Delivery System (PMA supplement)RxSight, Inc.

    Supplement type: Real-Time Process. Product code: PZK. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Jun 11, 2025device pma431d agoLeMaitre Vascular, Inc. — Artegraft Collagen Vascular Graft (PMA supplement)LEMAITRE VASCULAR INC

    Supplement type: 30-Day Notice. Product code: LXA. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 12, 2025device pma430d agoBiotronik, Inc. — Sentus QP Pacing Leads (PMA supplement)

    Supplement type: Normal 180 Day Track No User Fee. Product code: NKE. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 12, 2025device pma430d agoMedtronic, Inc. — Harmony Transcatheter Pulmonary Valve System (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 12, 2025device pma430d agoBiotronik, Inc. — Sentus QP Pacing Leads (PMA supplement)

    Supplement type: Normal 180 Day Track No User Fee. Product code: MRM. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 12, 2025device pma430d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 12, 2025device pma430d agoMedtronic Vascular — Endurant Stent Graft System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 12, 2025device pma430d agoRayner Intraocular Lenses , Ltd. — C-flex lntraocular Lens; C-flex Aspheric lntraocular Lens; 6.0 mm Aspheric lntraocular Lens; RayOne Aspheric; RayOne Sph (PMA supplement)

    Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Jun 12, 2025device pma430d agoMedtronic Vascular — Valiant Thoracic Stent Graft with the Captivia Delivery System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 13, 2025device pma429d agoMedtronic, Inc. — Aurora EV ICD DVEA3E4 (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 13, 2025device pma429d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 13, 2025device pma429d agoMedtronic, Inc. — PulseSelect™ Pulsed Field Ablation (PFA) system (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 13, 2025device pma429d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 13, 2025device pma429d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4, Brava CRT-D DTBC1D1; Bra (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 13, 2025device pma429d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG ADDRS1, VEDR01; Adapta, Versa, Sensia IPG ADDR03, ADDRL1, ADSR03, SESR01; Adapta, Versa, Sensi (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 13, 2025device pma429d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (PMA supplement)

    Supplement type: 30-Day Notice. Product code: PFV. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 13, 2025device pma429d agoMedtronic, Inc. — Consulta CRT-P C4TR01, Percepta Bipolar CRT-P W1TR01, Percepta Quadripolar CRT-P W4TR01, Serena Bipolar CRTP W1TR02, Ser (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 13, 2025device pma429d agoMedtronic, Inc. — Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗

    Week of Jun 16, 2025

    22
    ›Jun 16, 2025device pma426d agoBeckman Coulter, Inc. — Access Hybritech p2PSA (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: OYA. Advisory committee: IM. Decision: APPR

    full page →fda device pma ↗
    ›Jun 16, 2025device pma
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    426d ago
    Ventana Medical Systems, Inc. — VENTANA HER2 DualL ISH DNA Probe Cocktail (PMA supplement)MERIT MEDICAL SYSTEMS INC

    Supplement type: 30-Day Notice. Product code: NYQ. Advisory committee: PA. Decision: OK30

    full page →fda device pma ↗
    ›Jun 16, 2025device pma426d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Jun 16, 2025device pma426d agoMerz North America, Inc. — RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (PMA supplement)Sustained Therapeutics Inc

    Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Jun 16, 2025device pma426d agoMerz North America, Inc. — COAPTITE® (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LNM. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Jun 17, 2025device pma425d agoMedtronic, Inc. — Astra S DR MRI IPG, X3DR01; Astra S SR MRI IPG, X3SR01; Astra XT DR MRI IPG, X1DR01; Astra XT SR MRI IPG, X1SR01; Azure (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 17, 2025device pma425d agoABBOTT MEDICAL — Microny family of Pacemakers (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: LWO. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 17, 2025device pma425d agoMedtronic, Inc. — CareLink SmartSync Device Manager Base, 24970A (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 17, 2025device pma425d agoABBOTT MEDICAL — Aveir Leadless System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: PNJ. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 17, 2025device pma425d agoCooperVision, Inc. — MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QIT. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Jun 17, 2025device pma425d agoAtriCure, Inc. — Synergy Ablation System (PMA supplement)AtriCure, Inc.

    Supplement type: Normal 180 Day Track No User Fee. Product code: OCM. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 17, 2025device pma425d agoMedtronic, Inc. — Percepta Bipolar CRT- P, WlTR0l; Percepta Quadripolar CRT-P, W4TR01; Serena Bipolar CRT-P, W1TR02; Serena Quadripolar CR (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 17, 2025device pma425d agoABBOTT MEDICAL — Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: NIK. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 17, 2025device pma425d agoABBOTT MEDICAL — Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: NKE. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 17, 2025device pma425d agoABBOTT MEDICAL — Assurity, Assurity+, Endurity, Accent family of Pacemakers (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: DXY. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 17, 2025device pma425d agoNeuspera Medical, Inc. — Neuspera Sacral Neuromodulation System (PMA)

    Product code: EZW. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Jun 17, 2025device pma425d agoABBOTT MEDICAL — Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: LWS. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 17, 2025device pma425d agoABBOTT MEDICAL — Assurity MRI, Endurity MRI family of Pacemakers (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: LWP. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 17, 2025device pma425d agoAtriCure, Inc. — EPi-Sense Guided Coagulation System (PMA supplement)AtriCure, Inc.

    Supplement type: Normal 180 Day Track No User Fee. Product code: OCM. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 17, 2025device pma425d agoCooperVision, Inc. — MiSight 1 Day (omafilcon A) (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QIT. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Jun 18, 2025device pma424d agoMedtronic, Inc. — SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30

    full page →fda device pma ↗
    ›Jun 18, 2025device pma424d agoMedtronic, Inc. — MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $MMSI90.76+0.29%
    $MDT91.27+0.76%
    $LMAT82.38+0.55%
    $RXST
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $ATRC
    $MDT91.27+0.76%
    $MMSI90.76+0.29%
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $ATRC
    $MDT91.27+0.76%
    $MDT91.27+0.76%